Validation of an Alternative Biological Test to Increase the Detection Sensitivity of a Colon Tumour (VATNIMAD)
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|ClinicalTrials.gov Identifier: NCT01270360|
Recruitment Status : Completed
First Posted : January 5, 2011
Last Update Posted : June 15, 2015
|Condition or disease||Intervention/treatment|
|Colorectal Cancer||Device: COLOHYBRITEST OR VALIHYBRITEST|
This study search to validate a test by taking advantage of the biotechnical expertise from renowned academic research teams and mass screening organisation.
In order to reduce the cost of the present study the investigators will select in this preliminary study only those individuals who have a FOBT. However, we'll measure the blood level by using a I-FOBT test to quantify Haemoglobin concentration in stools. Furthermore, we'll use stool DNA to characterize microbiota according to the colonoscopy findings. In addition, the investigators believe it is important to include in the project, the creation of biological blood and urine collections from individuals having undergone both faecal tests and a reference colonoscopy. In the future, these collections will be made available to the national or international scientific community (after consent by the principal investigators) to validate any other molecular and/or protein marker including proteomic analysis by using MSS. The investigators will perform methylated DNA test in either stools or blood and will compare results to those of I-FOBT and colonoscopy.
A simplified molecular test based on a combination of the search for methylation anomalies (one PCR and/or dedicated microarray) a limited number of gene targets involved in colorectal carcinogenesis is available. The investigators will collect stools, urine, and blood in a period of 15 to 2 days prior to colonoscopy. The colonoscopy is performed in 50-74 years old asymptomatic individuals who have presented with a positive FOBT test under mass screening organisation. A final point will be performed 5 years after entry in the trial for all 1000 individuals in order to check occurrence (alternative absence) of any disease during this period and the type of the disease for those individuals who will be shown with normal colonoscopy and to verify evolution of those who will presented with a colon or rectal tumor. Likelihood value of marker in diseases occurring during the survey period will be calculated and prognostic values estimated in those with colon or rectal cancer.
|Study Type :||Observational|
|Actual Enrollment :||502 participants|
|Official Title:||Validation of a Non Invasive methylateDNA Test for te Diagnosis of Colorectal Tumour in Asymptomatic Individuals|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
asymptomatic subjects with positive FOBT
individuals having undergone a positive faecal occult blood test (FOBT) and a reference colonoscopy
Device: COLOHYBRITEST OR VALIHYBRITEST
Detection of human colon or rectal tumours by using a simplified molecular test based on either a combination of methylated DNA or protein marker(s) alone or considered together in biological fluids like blood, urine and stools
- To determine the performances (sensitivity, specificity and likelihood ratios) of a panel of blood and/or faecal molecular DNA markers [ Time Frame: 3 years ]To determine the performances (sensitivity, specificity and likelihood ratios) of a panel of blood and/or faecal molecular DNA markers
- To estimate the cost and cost-effectiveness of adding DNA molecular tests to FOBT positive patients prior to colonoscopy [ Time Frame: 3 years ]To estimate the cost and cost-effectiveness of adding DNA molecular tests to FOBT positive patients prior to colonoscopy
- To determine the performances (sensitivity, specificity and likelihood ratios) of a panel of blood and/or faecal molecular protein markers [ Time Frame: 3 years ]To determine the performances (sensitivity, specificity and likelihood ratios) of a panel of blood and/or faecal molecular protein markers
- To create biological collections for screening purposes (asymptomatic subjects) [ Time Frame: 3 years ]To create biological collections for screening purposes (asymptomatic subjects)
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01270360
|Henri Mondor Hospital|
|Creteil, France, 94010|
|Principal Investigator:||Iradj Sobhani, MD, PhD||Assistance Publique - Hôpitaux de Paris|